Market testing of dietary supplements and drugs underscores value of USP's public healt...(ober 12 2007 ConsumerLab.com called into...)

Date:11/12/2007

ober 12, 2007, ConsumerLab.com called into question the therapeutic interchangeability of two marketed extended release formulations of Buproprion Hydrochoride. For these drugs, primary responsibility for original and continuing market availability rests with the FDA working with manufacturers. USP notes that it does have drug product monographs for the involved formulations in the United States Pharmacopeia and that these monographs allow different dissolution requirements. This is appropriate on the assumption that the FDA has reviewed and found acceptable bioequivalence studies for formulations conforming to the monographs. USP does not verify drug products approved by the FDA.

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Contact: Sandra Kim sek@usp.org 301-816-8241 US Pharmacopeia Source:Eurekalert

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